Clinical Trial: Study Comparing Blood Levels of ReFacto and Advante in Hemophilia A

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: A Single Dose, Randomized, 2-Period Crossover Study in Patients With Hemophilia A to Evaluate the Pharmacokinetics of ReFacto (B-domain Deleted Recombinant Human

Brief Summary: The purpose of the study is to compare the pharmacokinetic parameters of ReFacto and Advate, using the chromogenetic substrate assay to measure plasma Factor VIII activity in plasma.

Detailed Summary:
Sponsor: Wyeth is now a wholly owned subsidiary of Pfizer

Current Primary Outcome: Pharmacokinetic measurement of area under the plasma Factor VIII activity in plasma versus time curve for 48 hours.

Original Primary Outcome: Pharmokinetic measurement of area under the plasma Factor VIII activity in plasma versus time curve for 48 hours.

Current Secondary Outcome: Number of subjects who experience any adverse event or develop Factor VIII inhibitor at study termination, 48 hours post dosing and/or at the final study visit within seven days of the 2nd period of the study.

Original Secondary Outcome: Number of subjects who experiece any adverse event or develop Factor VIII inhibitor at study termination, 48 hours post dosing and/or at the final study visit within seven days of the 2nd period of the study.

Information By: Wyeth is now a wholly owned subsidiary of Pfizer

Dates:
Date Received: September 11, 2005
Date Started: April 2005
Date Completion:
Last Updated: February 7, 2013
Last Verified: February 2013